Health Condition 1: F322- Major depressive disorder, singleepisode, severe without psychotic features
Conditions
Interventions
Intervention1: SNT-01 (Dextromethorphan 40 mg and Fluoxetine 10 mg): Treatment duration: 6 weeks
Total visits: 9 visits
Primary endpoint: Changes in the Montgomery- sberg Depression Rating Scale (MADR
Sponsors
Dr Ravi kishore Sadula
Eligibility
Inclusion criteria
Inclusion criteria: 1.Provides written informed consent to participate in the study, demonstrates an understanding of the procedures and study requirements, and agrees to adhere to study restrictions and attend required assessments. 2. Male or female, aged 18 to 75 years, inclusive. 3. Currently meets PHQ-9 criteria for Major Depressive Disorder without psychotic features, with a major depressive episode lasting at least 4 weeks at Visit 1. 4. Has a MADRS score more than 34 and a CGI-S score of greater than or equal to 4 at both Screening (Visit 1) and Baseline (Visit 2). 5. Exhibits normal physical examination findings and clinical laboratory test results from Screening (Visit 1), or has abnormal results deemed not clinically significant by the investigator. 6. Has a Body Mass Index between 18 and 40 kg/m , inclusive. 7. If female and of childbearing potential, has a negative urine pregnancy test at Visit 1 and Visit 2, is using an acceptable method of birth control (e.g., oral or parenteral contraceptives, intrauterine device, double-barrier method), and does not plan to become pregnant during the study. Long-term abstinence is acceptable if the subject agrees to use double-barrier contraception if they decide to engage in sexual intercourse.
Exclusion criteria
Exclusion criteria: 1. History of any depressive episode with psychotic or catatonic features (schizoaffective disorder- depression type is included). 2. History of any manic, hypomanic, or mixed episode, including bipolar disorder (Type 1 or Type 2 and substance-induced manic, hypomanic, or mixed episodes (e.g., induced by antidepressants). 3. History of Schizophrenia, or any other psychotic disorder, (schizoaffective disorder- depression type are included). 4. History of panic disorder, with or without agoraphobia, obsessive-compulsive disorder, bulimia or anorexia nervosa, any persistent neurocognitive disorder, any other anxiety disorder that has been the primary focus of clinical attention for the six months prior to Screening, with MDD being a secondary focus. 5. Known hypersensitivity to SNT-01 or any components of the formulation. 6. Discontinuation of antidepressant drugs for less than 2 half-lives prior to study randomization (e.g., monoamine oxidase inhibitor discontinued for at least 2 weeks). 7. History of treatment-resistant depression, defined as two or more failed treatments of adequate dose and duration during the current depressive episode. 8. Treatment with SSRI1 in the last 4 weeks. 9. Receipt of light therapy within 2 weeks prior to screening. 10. Post-traumatic stress disorder (PTSD), if active within the past 3 months prior to Visit 1. 11. Borderline or antisocial personality disorder, or any other disorder severe enough to interfere with study participation. 12. Alcohol or substance use disorder (excluding nicotine or caffeine), if active within one year prior to Visit 1. 13. Currently taking any other antitussive medications. 14. Psychiatric hospitalization during the current depressive episode. 15. Psychiatric symptoms secondary to any other general medical condition. 16. Clinically significant risk of suicide or harm to self or others, determined by any of the following: a. In the investigator s judgment, the subject poses a significant suicide risk based on psychiatric interview or Columbia-Suicide Severity Rating Scale (C-SSRS) responses at Visit 1 or Visit 2 (e.g., a yes response to questions 4 or 5 on the screening C-SSRS, with the most recent episode occurring within the current depressive episode). b. The subject has attempted suicide during the current depressive episode. c. A MADRS Item 10 score of greter than or equal to 5 at Visit 1 or Visit 2. 17. Use of drugs that are strong inhibitors of CYP2D6 (e.g., wion, paroxetine, quinidine), as specified in the FDA s Guidance for Industry: Drug Interaction Studies - Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations. 18. Use of drugs that either inhibit CYP2D6, the primary enzyme responsible for metabolizing SSRI1. 19. Current use, or use within 14 days before Visit 1, of monoamine oxidase inhibitors (MAOIs), linezolid, or intravenous methylene blue. 20. Use of opioids (e.g., codeine, oxycodone, morphine) within 14 days before Visit 1. 21. The use of any prohibited medications, MAOIs, routine benzodiazepines (including PRN), and antidepressants, is not allowed within one week or two half-lives of the medication whichever is longer before Visit 2. Specifically, there must be a two-week washout period for MAOIs. The safe withdrawal from benzodiazepine treatment should be determined by the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This objective will be assessed primarily through changes in the Montgomery- sberg Depression Rating Scale (MADRS) total score from baseline to week 6.Timepoint: Baseline (Day 0) to end of the study (Day 42). | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Ravi Kishore Sadula
Disha Psychiatric Care
Outcome results
None listed